Institutional Review Board

Informed Consent Form

Instructions for Completion

Consent forms should contain the basic elements, or additional elements, as appropriate, included in the Informed Consent section and follow the format outlined below:

Each page of the consent form should be on Wofford College letterhead, except in cases of collaborative projects when the letterhead from a hospital, university, etc. is acceptable. All letterhead must be the original, not a copy. The official stamp of the IRB will indicate the date of approval.
The consent form should be in language understandable to the subject or his or her legal representative. It must be written in a consistent voice: either first, second, or third person (not a combination).
If the research is externally funded, the funding agency should be listed under funding source.
The title of the study and the name, address, and telephone number of the investigator(s) follow immediately after funding source. The Principal Investigator's address and phone number, and the number of the IRB Office must appear on the consent form (this is the office number of the IRB chair). If the principal investigator is a student, the address and phone number of his/her advisor(s)/ supervisor(s) must also appear on the form.
Section I - Description of the Study. This section should include a statement that the study involves research, the purpose of the study, the reason for selecting the subject, the procedures to be used and identification of any procedures which are experimental, and the expected duration of the subjects participation, including anticipated follow-up.
Section II - Risks and Benefits to the Participant. Subjects should be informed about direct or indirect potential benefits to them or others or the absence of benefits. Potential or anticipated risks should also be specified. For research involving more than minimal risk, explanations as to whether compensation or medical treatments are available if injury occurs. The section must include the following: "If [I/you] have any concerns about the risks or benefits of participating in this study, [I/you] can contact [name of principal investigator and advisors/collaborators] or the IRB office at the numbers indicated above."
Section III - Costs and Payments to the Participant should be addressed explicitly, including a statement that payments will not be given if that is the case.
Section IV - Confidentiality must be specified as well as a description of procedures for protecting privacy, including specific information regarding how data will be stored to ensure security and confidentiality. The confidentiality statement must include in the statement a clause that reads "all information obtained in this study is strictly confidential unless disclosure is required by law."
Section V - Participant's Right to Withdraw from the Study must include a statement that the subject understands s/he is free to refuse to participate in or withdraw from the study at any time without adverse affects or loss of benefits, and that, if the participant withdraws, the data will be destroyed.
Section VI - Voluntary Consent by the Participant- The following voluntary consent paragraph must be used in all consent forms and must appear in boldface type: "I have read this consent form (or it has been read to me) and I fully understand the contents of this document and voluntarily consent to participate. All of my questions concerning this research have been answered. If I have any questions in the future about this study they will be answered by the investigator listed above or his/her staff. A copy of this form has been given to me."
Section VII - Other Considerations. Subject needs to be informed if significant new information relating to the study becomes available which may relate to his/her willingness to continue to participate, this information will be provided to him/her by the investigators.

Consent forms must provide space for the subject's signature, the date, and the signature of a witness, generally the member of the research staff obtaining the consent.

See Sample Consent Form.

Because children under the age of 18 may require simpler language than that provided in the sample consent form, a sample of the consent form for children can be found at Sample Child's Assent Form.

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